Dangerous Doses

Fighting Fraud in the Global Medicine Supply Chain

TIM K. MACKEY is a Senior Research Associate at the Institute of Health Law Studies at the California Western School of Law and a Ph.D. student in the Joint Doctoral Program in Global Health at the University of California, San Diego, and San Diego State University. BRIAN A. LIANG is Executive Director of the Institute of Health Law Studies and Director of the San Diego Center for Patient Safety. THOMAS T. KUBIC is President and Chief Executive Officer of the Pharmaceutical Security Institute.

The worldwide counterfeit drug market is huge and growing. The Center for Medicine in the Public Interest estimates that in 2010 the trade reaped around $75 billion, a 90 percent increase since 2005. Over the same period, the Pharmaceutical Security Institute (PSI), of which one of us is president, documented a huge increase in discoveries of counterfeit pharmaceutical products. In 2005, it recorded over 1,000 incidents; in 2010, it recorded more than twice that. The World Health Organization previously estimated that as much as 15 percent of the medicine in circulation around the world could be fake. These drugs occupy a wide spectrum of medications, and their quality is suspect; they can be mislabeled, tainted, adulterated, ineffective, or, in the worst cases, all of the above.

Given the lack of systematic, worldwide reporting, understanding the true scope of this public health problem is difficult. However, the broad strokes of it are well known. Traditionally, regions with weak regulatory structures, such as Africa, Latin America, and parts of Asia, have been both producers and consumers of counterfeit drugs. Multiple studies estimate that up to 50 percent of medicine in circulation in regions of Africa and Southeast Asia today is fake. And in 2009 alone, more than 20 million counterfeit pills were seized in China and Southeast Asia.

Data from recent fake drug busts indicate that, these days, counterfeit medicines are mainly produced in China and India. But once bottled, they are no longer sold only in the developing world. According to PSI data, between 2005 and 2010, all corners of the globe saw more discoveries of counterfeit medicine (Asia experienced a 246 percent increase, Europe a 131 percent increase, the Near East a 105 percent increase, and North America a 77 percent increase).

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